Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.

At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

Recent milestones include:

  • The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
  • Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
  • AMX0035 is currently under review with the European Medicines Agency
  • 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!


Amylyx is seeking a Lead, Clinical Pharmacology to lead neurology programs in early and late stages of clinical development - contributing to the design, planning, conduct, data analysis, interpretation, and reporting of Clinical Pharmacology studies. Reporting to the Head, Clinical Pharmacology and working closely with colleagues across research and development, the Clinical Pharmacology Lead applies their technical expertise to analyze, develop, validate, and implement quantitative models to inform key drug development decisions, and to make data-driven decisions based on pre-clinical and clinical information. You should be familiar with current practices in most of the following areas: clinical pharmacology, regulatory affairs, DMPK, translational sciences, bioanalytical method development and validation, and pharmacometrics.  This is a remote based position; the individual can live in the US, Europe, or Canada.


  • Overseeing clinical pharmacology studies on multidisciplinary program teams and working closely with clinicians, biostatisticians, translational scientists, medical writing, regulatory, and clinical operations colleagues to design, conduct and report clinical pharmacology trials including first-in-human, proof-of-concept, food effect (oral administration), drug-drug interaction, TQT, and special populations
  • Conducting quantitative pharmacology analyses including NCA, population PK, exposure/response, and PBPK to streamline drug development and guide critical decisions including dose selection within the target patient population including sub-populations
  • Collaborating with toxicologists and other non-clinical scientists to analyze translational models developed from preclinical data and to gain confidence in predicting human PK, efficacious doses, and dosage regimens
  • Leading the design and development of Clinical Pharmacology submission documents for regulatory filings, managing responses and leading resolutions to health authority clinical pharmacology queries and requests, and representing Clinical Pharmacology in regulatory interactions
  • Managing CROs assigned to conducting both pre-clinical and clinical pharmacology studies
  • Assisting with study design and interpretation of nonclinical pharmacology and toxicology studies including application of translational methods
  • Reviewing and providing inputs on the bioanalytical assay and validation report
  • Collaborating cross-functionally with other departments, such as Biostatistics, Global Medical Affairs, Scientific Communications, CMC, Clinical, Toxicology, Pharmacovigilance and Regulatory Affairs


  • PhD, MD, or PharmD in pharmacometrics, pharmaceutical sciences, or a related field
  • Minimum 3 years of bio/pharmaceutical experience in Clinical Pharmacology and Pharmacometrics
  • Proficiency with clinical pharmacology software and other computational tools (WinNonlin, NONMEM, etc.)
  • An established track record of scientific project management, working in cross-functional teams, and an ability to lead multiple initiatives in a dynamic and fast paced environment
  • Hands on experiences drafting clinical pharmacology documents (protocols, CSRs, etc.), reviewing statistical analysis plans (SAPs), and clinical pharmacology sections of regulatory submission documents (IBs, INDs, NDAs, briefing books, etc.)
  • Strong communication and time/project management skills


To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Apply for this Job

* Required

resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Amylyx’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Please reach out to our support team via our help center.